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Medifast 5 & 1 Plan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01211301
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : June 19, 2013
Medifast, Inc.
Information provided by (Responsible Party):
David Allison, Phd, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE September 28, 2010
First Posted Date  ICMJE September 29, 2010
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
Body weight [ Time Frame: 26 and 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
  • Waist circumference [ Time Frame: 26 and 52 weeks ]
  • Body composition as measured by bioelectrical impedence (BIA) [ Time Frame: 26 and 52 weeks ]
  • Body mass index [ Time Frame: 26 and 52 weeks ]
  • Low-density lipoprotein cholesterol (LDL) [ Time Frame: 26 and 52 weeks ]
  • High-density lipoprotein cholesterol (HDL) [ Time Frame: 26 and 52 weeks ]
  • Triglycerides [ Time Frame: 26 and 52 weeks ]
  • Glucose [ Time Frame: 26 and 52 weeks ]
  • Liver function tests [ Time Frame: 26 and 52 weeks ]
  • High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 26 and 52 weeks ]
  • Lipid hydroperoxides [ Time Frame: 26 and 52 weeks ]
  • Blood pressure [ Time Frame: 26 and 52 weeks ]
  • Appetite/satiety measures [ Time Frame: 26 and 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Medifast 5 & 1 Plan
Official Title  ICMJE Randomized Controlled Trial of the Medifast 5 & 1 Plan
Brief Summary The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a 26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based, reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52 weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite sensations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Body Weight
  • Weight Loss
  • Overweight
  • Nutrition Disorders
Intervention  ICMJE
  • Behavioral: Food-based, Reduced Energy Diet Plan
    Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.
  • Other: Medifast 5 & 1 Plan
    Participants randomized to the Medifast group will enroll online in the Medifast 5 & 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean & Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are >70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 & 1 Plan. The Medifast 5 & 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean & Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 & 1 Plan.
Study Arms  ICMJE
  • Active Comparator: Food-based, Reduced Energy Diet Plan
    Intervention: Behavioral: Food-based, Reduced Energy Diet Plan
  • Experimental: Medifast 5 & 1 Plan
    Intervention: Other: Medifast 5 & 1 Plan
Publications * Shikany JM, Thomas AS, Beasley TM, Lewis CE, Allison DB. Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss. Int J Obes (Lond). 2013 Dec;37(12):1571-8. doi: 10.1038/ijo.2013.43. Epub 2013 Apr 9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 35-50 kg/m2
  • Interested in weight loss
  • Computer with internet access
  • Any race or ethnicity
  • Fasting glucose <126 mg/dL at screening

Exclusion Criteria:

  • Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
  • Weight loss or gain of >5% body weight in past 6 months for any reason except post-partum weight loss.
  • Currently taking any medication that suppresses or stimulates appetite.
  • History of prior surgical procedure for weight control or liposuction.
  • Current smoker or quit smoking less than 6 months prior.
  • Any major disease, including:

    • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
    • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
    • Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
    • Uncontrolled hypertension: systolic blood pressure >160 mm Hg or diastolic blood pressure >95 mm Hg on treatment.
    • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
    • Active kidney disease.
    • Lung disease: chronic obstructive airway disease requiring use of oxygen.
    • Diagnosed diabetes (type 1 or 2), fasting hyperglycemia (blood glucose >126 mg/dL), or use of any anti-diabetic medications.
  • Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
  • A score on the Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) that exceeds the 90th percentile.
  • History of or current eating disorders, or an Eating Attitudes Test (EAT 40) score >30.
  • Active food allergies, particularly to wheat, gluten, soy or nuts.
  • Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
  • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable.
  • No regular source of health care.
  • Any active use of illegal or illicit drugs or history of illegal or illicit drug utilization within past year
  • Excessive alcohol intake, either acute or chronic defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
  • Willing to limit alcohol intake to zero
  • Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.
  • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01211301
Other Study ID Numbers  ICMJE F100625001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Allison, Phd, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Medifast, Inc.
Investigators  ICMJE
Principal Investigator: David B. Allison, PhD. University of Alabama at Birmingham
Principal Investigator: James M. Shikany, DrPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP